Reyataz (Atazanavir) Package Insert Revisions
January 16, 2008
The Reyataz (atazanavir) package insert was revised to include information regarding the administration of atazanavir and/or atazanavir/ritonavir with food, proton pump inhibitors, H2 receptor antagonists, acetaminophen, and fluconazole. Additionally, dosing information in patients with renal impairment was included.
Please refer to the complete labeling. Below are highlights of the major recent changes.
The Dosage and Administration section and Precautions: Drug Interaction Table 11 were updated to include drug interaction information regarding the use of Reyataz and proton pump inhibitors and H2-receptor antagonists.
The dose recommendations for therapy-na?ve patients receiving H2-receptor antagonists or proton pump inhibitors are the following:
The dose recommendations for therapy-experienced patients receiving H2-receptor antagonists or proton pump inhibitors are the following:
In addition, the Dosage and Administration section was updated to provide dosing information in patients with renal impairment as follows:
For patients with renal impairment, including those with severe renal impairment who are not managed with hemodialysis, no dose adjustment is required for Reyataz. Treatment-naive patients with end stage renal disease managed with hemodialysis should receive Reyataz 300 mg with ritonavir 100 mg. Reyataz should not be administered to HIV-treatment experienced patients with end stage renal disease managed with hemodialysis.
No dose adjustments are needed when Reyataz is co-administered with acetaminophen or fluconazole.
The Clinical Pharmacology section was updated to include the following information:
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